PepGen Inc. announced that it received a clinical hold notice from the U.S. Food and Drug Administration (FDA) regarding its Investigational New Drug (IND) application. This hold pertains to the initiation of the CONNECT2-EDO51 clinical trial in patients with Duchenne muscular dystrophy (DMD).
The FDA indicated it would provide an official clinical hold letter to PepGen within 30 days, detailing the reasons for the hold. A clinical hold prevents the company from administering the investigational drug to subjects in the proposed study in the U.S.
The CONNECT2 study is designed as a Phase 2 multinational, double-blind placebo-controlled, multiple ascending dose, 25-week clinical trial of PGN-EDO51. While the study is open in the United Kingdom, PepGen stated it intends to work closely with the FDA to address their questions as expeditiously as possible. The separate CONNECT1-EDO51 study in Canada continues as planned, with the 10 mg/kg dose cohort fully enrolled.
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